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Bryanek Regulatory

PROVIDING CMC REGULATORY CONSULTING FROM THE HISTORIC HEART OF CORNWALL

SERVICES:

  • Preparation of Global regulatory strategies
  • Manufacturing site rationalisation (site transfers)
  • International CMC variations
  • EU Post Marketing Applications
  • Authoring Module 3 documentation
  • CMC authoring experience with drug products and drug substances
  • Ensuring compliance with current regulatory requirements and standards
  • Gap analysis and Compliance projects
  • Review of CMC data
  • Renewals
  • Responding to regulatory authority questions
Meeting your requirements either on-site or remotely.

To discuss any other requirements you may have, please get in touch.